Type 2 Diabetesvirtual careNCT06814184
Virtual Diabetes Care for Adults With Type 2 Diabetes on Medicaid and Insulin Therapy
A study testing app-based nurse-led virtual diabetes care in people with Type 2 Diabetes, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial summary
This 12-month pilot tests a nurse-led, app-based intervention to improve diabetes self-management for Medicaid patients. It includes MyChart messaging to give education, phone help on problem-solving with clinicians, and using a diabetes app to track data. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- app-based nurse-led virtual diabetes care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A1C >7 for age 18-64, A1C>8 for age 65 or older within 12 months prior baseline
- A1C>7 for age 18-64, A1c>8 for age 65 or older at baseline
- Medicaid recipient or dual Medicaid and Medicare recipient
- Age 18 or older
- Type 2 diabetes
- On insulin therapy
Show all 10Show fewer
- Owning and using Android or iOS smartphone for at least 6 months
- English proficiency
- Adequate vision to read text messages on their current smartphone
- Smartphone use proficiency. Smartphone proficiency will be self-reported and determined by telephone as the ability to use a smartphone in ways other than emailing, texting, and making phone calls.
Who cannot join
- Pregnancy
- Patients with cognitive impairment who will be screened with the Six-Item Screener to Identify Cognitive Impairment Among Potential Research Subjects.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Rutgers Health Family Medicine at Monument Square
New Brunswick, New Jersey, 08901
Medical Director, 732-235-8993, clarkec@rwjms.rutgers.edu
- Recruiting
University Medical Group General Internal Medicine
New Brunswick, New Jersey, 08901
Shirin Hastings, 732-908-1437, hastinse@rwjms.rutgers.edu
About this study
Official title: Nurse-led App Intervention to Improve Glycemic Control in Patients With Insulin-treated Type 2 Diabetes on Medicaid
This 12-month pilot tests a nurse-led, app-based intervention to improve diabetes self-management for Medicaid patients. It includes MyChart messaging to give education, phone help on problem-solving with clinicians, and using a diabetes app to track data. The study aims to enhance self-management behaviors through health technology.
Read the detailed description
Guided by the Self- and Family Management Framework, which specifies facilitators and barriers to self- management behaviors, this project tests strategies for delivering virtual diabetes care to help Medicaid patients and clinicians use health information technology to support self-management behaviors. It is a 12-month pilot nurse-led, app-based behavioral intervention consisting of three evidence-based interventions: (1) education on A1C results and goal-setting via MyChart, the Epic electronic health record's patient portal; (2) a problem-solving action plan developed collaboratively by clinicians and patients; and (3) remote monitoring via mySugr, a top- rated diabetes app, to track blood glucose and identify the need for treatment adjustments.
- Conditions
- Type 2 Diabetes
- Being tested
- app-based nurse-led virtual diabetes care
- Keywords
- diabetes app, behavioral intervention, self-management, diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
app-based nurse-led virtual diabetes careBehavioural
A nurse-led, app-based behavioral intervention consisting of (1) education via MyChart messaging, (2) problem solving with an action plan via phone, and (3) remote patient monitoring via mySugr app to identify the need to adjust treatment
| Study group | Role | What they receive |
|---|---|---|
| Experimental with intervention | Experimental | Intervention starts at enrollment Receives: Behavioral: app-based nurse-led virtual diabetes care |
| Delayed Intervention | Other | Intervention delivery 3 months after enrollment Receives: Behavioral: app-based nurse-led virtual diabetes care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control: glycated hemoglobin AIC
Electronic health record extracted lab test drawn at baseline, 3, 6, 9, and 12 months
Measured: baseline, 3, 6, 9, and 12 months
Glycemic control - the rate of pre-prandial blood glucose readings in target range
Home monitoring glucometer at baseline and diabetes app report containing blood glucose readings at home for 3, 6, 9, and 12 months. It is calculated from the number of BG that met the target divided by the total number of BG tested.
Measured: baseline, 3, 6, 9, and 12 months
Glycemic control - the rate of peak postprandial blood glucose reading in target range
Blood glucose reading obtained from patient's home monitoring glucometer at baseline and diabetes app report containing blood glucose readings at home for 3, 6, 9, and 12 months. It is calculated from the number of BG that met the target divided by the total number of BG tested.
Measured: baseline, 3, 6, 9, and 12 months
Secondary outcomes (8)
Diabetes Knowledge Test 2 (23 iems) for knowledge change
This scale assesses the knowledge of individuals regarding diabetes management and self-care. 0 is minimal and 23 is maximal. Higher is better outcome reflecting high knowledge.
Measured: baseline, 3, 6, 9, and 12 months
Diabetes Empowerment Scale Short 28 items for self-efficacy change
The DES-28 has been validated and is considered a reliable tool for assessing the psychosocial aspects of diabetes management, making it useful for various educational and psychosocial interventions related to diabetes. 28 is minimal, 140 is max. Higher is better outcome, reflecting greater empowerment and self-efficacy in managing diabetes.
Measured: baseline, 3, 6, 9, and 12 months
AHC Health-Related Social Needs Screening Tool (10 items) for Social Determinants of Health Change
It help healthcare providers identifies the social needs of their patients, which can inform interventions and resource allocation. 0 is minimal, 10 is max. Higher score is greater number of identified health-related social needs, which may suggest worse outcomes in terms of social determinants of health.
Measured: baseline, 3, 6, 9, and 12 months
Brief Cope Inventory (28 items) for effective and ineffective ways to cope with stressful life events.
The Brief Coping Inventory is a 28-item measure that assesses 14 distinct coping strategies, with two items representing each strategy. It provides insight into how individuals manage challenges related to diabetes and general life stressors. Each item is rated on a 4-point scale ranging from 1 ("not at all") to 4 ("a lot").
Scores for each coping strategy range from 2 to 8, with higher scores indicating greater use of that specific coping style. The total score for the full inventory ranges from 28 to 112, with higher overall scores reflecting a greater reliance on coping strategies across domains.
Measured: baseline, 3, 6, 9, and 12 months
Diabetes Distress Scale (17 items) for quality of life change
Measures emotional distress related to managing diabetes, with scores for each item ranging from 1 ("not a problem") to 6 ("a very serious problem"). It is a valuable tool for identifying patients who may need additional support in managing the emotional burdens associated with diabetes. 17 is minimal, 102 is max. Higher scores indicate greater diabetes-related distress, which is generally considered worse for overall well-being and diabetes management. Scores are typically categorized as little/no distress, moderate distress, or high distress to guide interventions.
Measured: baseline, 3, 6, 9, and 12 months
Summary of Diabetes Self-Care Activities Measure (11 items) for Self-management activity changes
It is a reliable and valid tool for evaluating diabetes self-management behaviors and is useful in both research and clinical settings. 0 is minimal indicating no self-care activities performed, 11 is max indicating all self-care activities performed. Higher score indicate Measure consists of 11 items that assess various aspects of diabetes self-management.
Measured: baseline, 3, 6, 9, and 12 months
Blood Glucose (BG) testing frequency change
The number of blood glucose readings obtained from patient's home monitoring glucometer at baseline and the number of blood glucose readings listed in the diabetes app report at home for 3, 6, 9, and 12 months.
Measured: baseline, 3, 6, 9, and 12 months
Diabetes Numeracy Test short (15 items) for knowledge change
This test assesses diabetes-related numeracy skills that are essential for effective self-management of diabetes, such as interpreting blood glucose readings and calculating carbohydrate intake. 0-15, 0 is minimal with no correct answer, 15 is max. Higher is better outcome reflecting higher numeracy.
Measured: baseline, 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start1 Apr 2026
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clinic 1 starts enrollment and intervention on 4/1/2026, while Clinic 2 starts enrollment but intervention starts on 7/1/2026. We cannot deliver intervention the same time parallel step-wedge, give two clinics intervention can't deliver intervention same time
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Helen NC Chen PhD, FNP, Rutgers, The State University of New Jersey
- Investigators
- Helen NC Chen, PhD, Principal investigator, Rutgers School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814184
- Sponsor's protocol ID
- Pro2025000096
- Acronym
- virtual care
- Status last verified
- Apr 2026
- First submitted
- 1 Feb 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared. Each participant will be given a unique study identification number that will be used on all study forms and data files. Each participant's identifying data will be separated from the study data. All data will be de-identified with a participant code number. The code linking a participant to their code number will be maintained in a separate file on a secure server at Rutgers (e.g., Microsoft Teams, Box).
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-led App Intervention to Improve Glycemic Control in Patients With Insulin-treated Type 2 Diabetes on Medicaid
- ClinicalTrials.gov ID
- NCT06814184
- Acronym / sponsor ID
- virtual care / Pro2025000096
- Conditions
- Type 2 Diabetes
- Keywords
- diabetes app, behavioral intervention, self-management, diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This 12-month pilot tests a nurse-led, app-based intervention to improve diabetes self-management for Medicaid patients. It includes MyChart messaging to give education, phone help on problem-solving with clinicians, and using a diabetes app to track data. The study aims to enhance self-management behaviors through health technology.
Detailed description
Guided by the Self- and Family Management Framework, which specifies facilitators and barriers to self- management behaviors, this project tests strategies for delivering virtual diabetes care to help Medicaid patients and clinicians use health information technology to support self-management behaviors. It is a 12-month pilot nurse-led, app-based behavioral intervention consisting of three evidence-based interventions: (1) education on A1C results and goal-setting via MyChart, the Epic electronic health record's patient portal; (2) a problem-solving action plan developed collaboratively by clinicians and patients; and (3) remote monitoring via mySugr, a top- rated diabetes app, to track blood glucose and identify the need for treatment adjustments.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Clinic 1 starts enrollment and intervention on 4/1/2026, while Clinic 2 starts enrollment but intervention starts on 7/1/2026. We cannot deliver intervention the same time parallel step-wedge, give two clinics intervention can't deliver intervention same time
| Arm | Type | Receives |
|---|---|---|
| Experimental with intervention | Experimental | Behavioral: app-based nurse-led virtual diabetes careIntervention starts at enrollment |
| Delayed Intervention | Other | Behavioral: app-based nurse-led virtual diabetes careIntervention delivery 3 months after enrollment |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- A1C >7 for age 18-64, A1C>8 for age 65 or older within 12 months prior baseline
- A1C>7 for age 18-64, A1c>8 for age 65 or older at baseline
- Medicaid recipient or dual Medicaid and Medicare recipient
- Age 18 or older
- Type 2 diabetes
Key exclusion criteria (2 listed)
- Pregnancy
- Patients with cognitive impairment who will be screened with the Six-Item Screener to Identify Cognitive Impairment Among Potential Research Subjects.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| app-based nurse-led virtual diabetes careA nurse-led, app-based behavioral intervention consisting of (1) education via MyChart messaging, (2) problem solving with an action plan via phone, and (3) remote patient monitoring via mySugr app to identify the need to adjust treatment | Behavioural | Delayed Intervention, Experimental with intervention |
Primary outcome
Glycemic control: glycated hemoglobin AIC
Time frame: baseline, 3, 6, 9, and 12 months
Electronic health record extracted lab test drawn at baseline, 3, 6, 9, and 12 months
Glycemic control - the rate of pre-prandial blood glucose readings in target range
Time frame: baseline, 3, 6, 9, and 12 months
Home monitoring glucometer at baseline and diabetes app report containing blood glucose readings at home for 3, 6, 9, and 12 months. It is calculated from the number of BG that met the target divided by the total number of BG tested.
Glycemic control - the rate of peak postprandial blood glucose reading in target range
Time frame: baseline, 3, 6, 9, and 12 months
Blood glucose reading obtained from patient's home monitoring glucometer at baseline and diabetes app report containing blood glucose readings at home for 3, 6, 9, and 12 months. It is calculated from the number of BG that met the target divided by the total number of BG tested.
8 secondary outcomes
Diabetes Knowledge Test 2 (23 iems) for knowledge change
Time frame: baseline, 3, 6, 9, and 12 months
Diabetes Empowerment Scale Short 28 items for self-efficacy change
Time frame: baseline, 3, 6, 9, and 12 months
AHC Health-Related Social Needs Screening Tool (10 items) for Social Determinants of Health Change
Time frame: baseline, 3, 6, 9, and 12 months
Brief Cope Inventory (28 items) for effective and ineffective ways to cope with stressful life events.
Time frame: baseline, 3, 6, 9, and 12 months
Diabetes Distress Scale (17 items) for quality of life change
Time frame: baseline, 3, 6, 9, and 12 months
Summary of Diabetes Self-Care Activities Measure (11 items) for Self-management activity changes
Time frame: baseline, 3, 6, 9, and 12 months
Blood Glucose (BG) testing frequency change
Time frame: baseline, 3, 6, 9, and 12 months
Diabetes Numeracy Test short (15 items) for knowledge change
Time frame: baseline, 3, 6, 9, and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Individual participant dataSharing planned: No. IPD will not be shared. Each participant will be given a unique study identification number that will be used on all study forms and data files. Each participant's identifying data will be separated from the study data. All data will be de-identified with a participant code number. The code linking a participant to their code number will be maintained in a separate file on a secure server at Rutgers (e.g., Microsoft Teams, Box).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Helen NC Chen, PhD principal investigator
Rutgers School of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing app-based nurse-led virtual diabetes care in people with Type 2 Diabetes, run by Rutgers, The State University of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Helen NC Chen, PhD ((908) 466-3953, helen.nc.chen@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic control: glycated hemoglobin AIC (time frame: baseline, 3, 6, 9, and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.